Product code QGG

Device name

Esophageal Sheath With Distal Balloon Anchor

Medical specialty

Gastroenterology, Urology

Device class

2

Regulation number

876.1510

Review panel

GU

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

Used to provide an endoluminal pathway to facilitate insertion of an endoscope or other specifically validated device into the upper gastrointestinal tract. A distal balloon anchor assists in keeping the sheath in place to facilitate positioning of the endoscope or other specifically validated device.

Source

FDA openFDA device classification dataset